FDA 483 - Future Pak Ltd. - October 02, 2019

Future Pak ltd. in Wixom, MI, a dietary supplement manufacturer, was cited for failing to conduct appropriate in-process tests to ensure product strength specifications. An inspection revealed that a production employee did not correctly measure in-process weight specifications for charcoal capsules, deviating from the Master Batch Manufacturing Record. This indicates a lapse in quality control during manufacturing operations.